Qualitest TEMAZEPAM 7.5mg Capsules Recall: Failed Stability Specifications
Qualitest Pharmaceuticals recalls 7.5mg TEMAZEPAM capsules due to failed stability tests. These prescription-only capsules may degrade over time, posing safety risks. Check your prescription label for NDC 0603-5891-21.
Lower-risk recall
Failed Stability Specifications
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What happened, in plain English
Qualitest Pharmaceuticals is recalling prescription 7.5mg TEMAZEPAM capsules that failed stability testing. This means the medication could degrade over time, potentially affecting safety and effectiveness. Read more at govinfonow.com/recall/42109-qualitest-temazepam-7-5mg-capsules-recall-failed-stability-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/42109-qualitest-temazepam-7-5mg-capsules-recall-failed-stability-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0326-2017
Cite this page
“Qualitest TEMAZEPAM 7.5mg Capsules Recall: Failed Stability Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42109-qualitest-temazepam-7-5mg-capsules-recall-failed-stability-specifications. Based on FDA recall #D-0326-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0326-2017%22&limit=1).
Why it’s dangerous
The capsules failed stability specifications, meaning they may degrade over time. This could lead to reduced effectiveness or potential safety issues if the medication is no longer stable.
Who’s affected
Prescription holders with the specific 7.5mg TEMAZEPAM capsules (NDC 0603-5891-21) manufactured in Huntsville, AL. Patients on this medication are most at risk if they have the recalled batch.
How to tell if you have this one
Check your prescription label for the NDC code 0603-5891-21. The capsules are 7.5mg, 100-count bottles, manufactured for Qualitest Pharmaceuticals in Huntsville, AL, with an expiration date of 08/17.
- Brand
Qualitest Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Capsules
Look for the NDC code 0603-5891-21 on the prescription label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these capsules?
No, but you should check if you have the recalled batch and contact your pharmacist for advice.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0326-2017 (December 22, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0326-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.